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FDA Seeks Comments on Electronic Positioning Chair Exemption

06/12/2015

Federal Register Notice: FDA has received a petition requesting exemption from the premarket notification requirements for an elec...

Review Period Set for Xeljanz

06/12/2015

Federal Register Notice: FDA has determined the regulatory review period for Pfizer’s Xeljanz (tofacitinib citrate) is 3,947...

OMB Approves Info on Risk/Benefit Perception Scale

06/09/2015

Federal Register Notice: FDA’s collection of information entitled “Risk and Benefit Perception Scale Development,&rdqu...

OMB OKs Info on Tobacco Prevention

06/09/2015

Federal Register Notice: FDA’s collection of information entitled “Evaluation of the Food and Drug Administration&rsqu...

OMB OKs Info on Single-Use Devices

06/09/2015

Federal Register Notice: FDA’s collection of information entitled “Prominent and Conspicuous Mark of Manufacturers on ...

OMB OKs Info on DTC Ads

06/03/2015

Federal Register Notice: FDA’s collection of information entitled, “Disclosure Regarding Additional Risks in Direct-to...

OMB OKs Info on Orphan Products Development

06/03/2015

Federal Register Notice: FDA’s collection of information entitled, “Guidance for Industry, Researchers, Patient Groups...

Info on Biosimilars User Fee Sent to OMB

06/03/2015

Federal Register Notice: FDA’ s proposed collection of information, “Biosimilars User Fee Cover Sheet; Form FDA 3792,&...

Comments Extended on Compounded Drug MOU

06/03/2015

Federal Register Notice: FDA is extending the comment period until 7/20 for a draft standard memorandum of understanding (MOU) ent...

FDA Seeks Notification of Generic Drug User Fee Meetings

06/03/2015

Federal Register Notice: FDA is requesting that public stakeholders, including patient and consumer advocacy groups, health care p...